Cervical-pudendal indwelling catheter set with tissue piercing means



United States Patent O ABSTRACT F THE DISCLSURE A cervical-pudendal indwelling catheter set especially suited for transvaginal nerve block regional anesthesia in obstetrics and gynecology. This set includes a closed outer sleeve housing a slidably mounted catheter having a hypodermic needle sealingly secured to the distal end thereof. The proximal end of the catheter is sealingly attached to a slidable combination reseal injection site and locking member which cooperates with a collar on the proximal end of the sleeve to displace and lock the catheter in an operating position. During operation, the catheter is displaced so the needle pierces the end Wall of the outer sleeve, and is inserted into tissue. Anesthetic is introduced at the reseal site by injection, for flow through the catheter and needle into tissue.

This invention is directed to a novel and useful catheter and more specifically to a flexible indwelling catheter adapted to be transvaginally inserted and to remain in position for prolonged periods of time for sequential administration of anesthetic therethrough.

The first stage of labor, during parturition, may readily last up to 10 hours, and often the use of a local anesthetic is desirable to provide analgesia. Prior to this invention, a conventional method of introducing a local anesthetic was to inject the anesthetic paracervically to provide a local analgesic effect. Because of the limited duration of anesthesia and often long duration of the first stage of labor, repeated entries were necessary. Furthermore, frequent vaginal re-entry would, of course, be an inconvenience to the doctor and patient, as well as serving to expose the mother and foetus to possible sources of infection with each succeeding re-entry.

The instant apparatus overcomes the foregoing objections of prior art devices and techniques by providing an indwelling flexible catheter, the distal end of which is inserted in the base of the broad ligaments lateral to the cervix and the proximal end of which is taped to the abdomen or thigh of the patient, the proximal end having a resealable injection site through which an analgesic may be periodically introduced by means of a syringe or other suitable means without necessitating any further vaginal entry. In normal operation, the above apparatus would be used in pairs, whereby one catheter is placed in the broad ligament on the right side of the cervix and a second catheter is placed in the broad ligament on the left side of the cervix. This apparatus provides increased safety because the single entry considerably lessens any possibility of infection and since doses of anesthetic can be administered frequently, the possibility of adverse reaction from excessively large doses is eliminated. Furthermore, the flexibility of the catheter permits descent and movement of the uterus during contractions, with diminished possibility of injury thereto.

The apparatus of the instant invention comprises a closed flexible outer sleeve in which a length of plastic tubing, having a needle sealingly secured to the distal end thereof, is slidably mounted. The proximal end of the interior length of plastic tubing is sealingly attached to a slidable combination reseal injection site and locking member, which cooperates with a collar on the proximal end of the sleeve to displace and lock the interior tube when the catheter is placed in the appropriate position, so that the needle pierces the end wall of the outer sleeve and is inserted in body tissue, so that an anesthetic introduced at the reseal injection site is injected into the tissue in which the needle is lodged.

It is therefore an object of this invention to provide a flexible catheter capable of indwelling within a body cavity for extended periods of time.

A further object of this invention is to provide a flexible catheter having a ilexible inner tube slidably mounted within a sealed flexible outer sheath.

Yet another object of this invention is t-o provide a novel locking mechanism for a flexible catheter comprising an inner tube and an outer sheath, for securely fastening the inner tube and said outer sheath,

A concomitant object of this invention is to provide an indwelling flexible catheter for the local administration of anesthesia during the first stage of labor, comprising an inner tube having a needle at one end and a multiple injection site at the other end and slidably, lockably mounted within a closed outer sheath.

These and other objects of this invention will be readily understood and appreciated from the succeeding detailed description of the invention, when taken in conjunction with the accompanying drawing, in which:

FIGURE 1 is a top elevation, partly in section, of the catheter of this invention in a sterile package;

FIGURE 2 is a sectional view, taken along the longitudinal axis of the catheter of FIGURE 1, showing the catheter in position for bodily insertion;

FIGURE 3 is a partial section, similar to FIGURE 2, showing the catheter in its displaced position, with a hypodermic needle inserted through the multiple injection site for the introduction of an anesthetic through the needle of the catheter into a patient.

Referring to the drawing, FIGURE 1 shows a catheter packaged ready for use in a sterile package generally designated as 10 and comprising a polyethylene sheath 11 encompassing the catheter and having heat-sealed ends 12. The catheter per se comprises an outer sheath or covering sleeve i6, a catheter or tube 22 slidably mounted within the outer sheath 16 and having a male adapter 26 sealingly united to the proximal end thereof, and a cannula 24 sealingly united to the distal end thereof, with a multiple injection site cap member 44 secured to the proximal end of the adapter member 26.

The catheter 22 comprises an elongated tube formed of butyrate plastic or nylon material of a flexible and somewhat stiff nat-ure. A conventional cannula 24 is fused to the distal end of catheter 22; the male adapter member 26, which is composed of rigid Implex), a modii'icd methyl methacrylate plastic, is sealed over the proximal end of the catheter 22.-

Male adapter member 26 has a pair of longitudinally spaced shoulders 33 and 34 peripherally formed at the distal end thereof, and a hollow recessed portion 42 formed at the proximal end thereof. The hollow end portion is spaced by a shoulder ttl from a stop ring or flange 38 which is in turn spaced from peripheral shoulder or locking ri-b 36 by a recessed notch portion 37.

Catheter 22 is slidably mounted Within outer sheath 16; the outer sheath 16 comprises a sleeve portion i7 having a thin diaphragm 30 sealingly closing the distal end thereof, and an enlarged female end portion 20 at the proximal end thereof. The hollow female end portion 20 is connected to the sleeve portion i7 by a finger grip or flange 18 which provides a gripping member for manipulation thereof. The hollow female end 20 of outer sheath 16 has a constant diameter inner surface which is connected by a necked-down face or section 21 to the interior of the sleeve portion 17. The proximal end of the female member 20 has .an integral resilent rib 32 extending inwardly and comprising a substantially vertical inner face and an outer beveled face. The outer sheath 16 is unitary member preferably formed of polyethylene, although vinyl or other plastics .are also suitable, so long as the outer sheath is of a flexible and easily bendable nature, and sufciently rigid to permit bodily insertion thereof without excess bending. Latex or filled rubber reseal cap 44 -has an integral inner sheath 46 which seats within hollow end 42 of male adapter 26 and an outer sheath 45 which seats over the hollow end 42 of the male adapter. The reseal cap has a circular ridge 48 on the -proximal face thereof which forms an entry guide ring overlying entry section 47, and the entire reseal cap unit is sealably joined to the hollow end of the male adapter member 26 by means of a suitable friction ring 27 or by adhesive or similar fastening means. A plastic removable hood 28 having -a sheath portion 29 seats over the reseal cap member 44 `and the sheath 29 frictionally engages shoulder 40 to maintain the sterility of the reseal cap member.

As noted hereinbefore, resilient rib 32 had a substantially vertical inner face and a beveled outer face., and the proximate faces of shoulders 33 and 34 are respectively matingly rectangular and beveled so that a locking function, to prevent substantial longitudinal displacement, is accomplished when resilent rib 32 is seated in the notch 37 between shoulders 33 and 34, as best seen in FIG- URE 3. The notch 37 is approximately equal in length to the longitudinal dimension of resilient rib 32 so that when the male adapter member 26 is in the position shown in FIGURE 3, resilient rib 32 is securely gripped between the proximal face of locking rib 36 and the distal face of flange 38. Flange 38 serves as a stop member for limiting the longitudinal displacement of male adapter member 26, so that when the male adapter is in the position shown in FIGURE 3, it is securely locked in place and cannot be further displaced in the distal direction. Locking rib 36 has -a vertical proximal face and la tapered distal face so that when the male adapter is displaced from the position of `FIGURE 2 to the position of FIGURE 3, the tapered face of locking rib 36 will serve to expand resilient rib 32 so that it will easily seat in notch 37, but whereby the vertical wall contact between the proximal face of locking rib 36 and the distal face of resilient rib 32 provides a means to prevent the male adapter 26 from being inadvertently withdrawn from female member 20. In some circumstances it is desirable that the male adapter be withdrawable from female member 20. This can be facilitated by rounding the surfaces of locking rib 36, so that a locking function is performed thereby, while still permitting reasonably facile removal of the male adapter.

`In operation, a catheter in accordance with this invention is vaginally inserted and the distal end of the catheter is guided by the fingers of the physician until the diaphragm at the end of sheath 17 is in a position abutting the broad ligament lateral to the cervix. When the catheter is in this position, the physician would grasp nger grip 18 between the forefinger and middle linger of the free hand and press hood 28 with the thumb of the free hand, pushing the thumb toward the finger grip 18. Upon displacement of the male adapter member by this operation, catheter 22, which is slightly rigid, is displaced to force needle 24 through flexible diaphragm 30 and into said broad ligament tissue.

The sleeve portion of the outer sheath 16 is approximately 11 inches long and the female portion 20 of the outer sheath is approximately I1/2 inch long. When the catheter of this invention is inserted, approximately 7 inches of the sleeve portion remains external to the patients body, and because of the flexibility of catheter 22 and sleeve portion 17, the external part of the catheter and sleeve portion can be bent upwards and taped to the patients abdomen.

It will be appreciated that in the procedure developed for the use of the catheter of this invention, a pair of catheters are utilized, the needle of each catheter being inserted respectively in one of the right or left broad ligaments lateral to the cervix, and the proximal end of each respective catheter is bent upward and taped to the appropriate side of the patients abdomen or thigh. The protective hood 28 may be then slipped off to expose reseal cap 44, which may then be entered with the needle 52 on a hypodermic syringe 50, for introduction of anesthetic into the patient. When the anesthetic has been introduced, the hypodermic needle is removed from the reseal cap, and a later administration of anesthetic can be effected by aseptic reintroduction of a hypodermic needle through the reseal cap, as many times as may be necessary, During the time of administration of local anesthetic, which may be as long as l0 hours, the indwelling catheters are allowed to remain in position. When it is desired to remove the catheters, the tapes holding the catheters in place are removed, and the catheters withdrawn. At this point the unit can be used for performing a transvaginal pudendal nerve block, i.e. before complete withdrawal. It will be observed that the length of the uniform diameter portion of female member 20 and the spacing between notch 37 and shoulder 34 will be determinative of the extent to which the needle 24 extends beyond diaphragm 30. In catheters designed for various purposes it may be desirable to have a greater or lesser displacement of the needle, and this dimension of displacement can be varied by variance of the dimensions related immediately above, or by varying the length of catheter 22, or outer sheath 16.

It will be appreciated that although polyethylene and vinyl have been disclosed as suitable materials for outer sheath member 16, any other physiologically acceptable flexible, somewhat stiff plastic may be substituted therefor. The stiffness of the member must be sufficient to enable an effective lock to be accomplished at the female end. Furthermore, although catheter 22 has been suggested to be construed of butyrate plastic or nylon, other plastics and other materials which are Hexible and relatively rigid may be substituted in lieu thereof. The degree of rigidity and flexibility of catheter 22 are such that the catheter may be inserted and displaced without buckling and subsequently easily bent for taping to the paticnts abdomen. The rigid male adapter which, although indicated to be of Implex plastic, may also be formed of methacrylate, styrene or other suitable rigid materials. The removable hood 28 may be formed of any suitable plastic or other material.

Although the instant catheter construction has been described for use as a vaginally, indwelling catheter for the production of paracervical block, it is apparent that the inventive principles of the disclosed embodiment may be applied to catheters suitable for other purposes without departing from the spirit and scope of this invention, as defined in the appended claims.

Having thus described this invention, what is claimed is:

1. A catheter assembly comprising an elongated sleeve terminating in an integral, pierceable sealing diaphragm at the distal end thereof and having an open proximal end, a stiff catheter member slidably mounted in said sleeve, the distal end thereof terminating in a hollow piercing point inboard said diaphragm, closure means sealed to the proximal end of said catheter member and frictionally slidably engaging the inner wall of said sleeve, locking means for locking said catheter to the inner wall of said sleeve alternately in a first and in a second locked position, and means extending beyond the proximal end of said sleeve and secured to said closure means for displacing said catheter member from a first locked storage position whereby said catheter is inboard said diaphragm to a second locked operating position whereby said piercing point extends through and partially beyond said diaphragrn.

2. A catheter assembly comprising an elongated sleeve terminating in an integral pierceable diaphragm at the distal end thereof and having an open proximal end, a stiff catheter member slidably mounted in said sleeve, locking means releasably locking said catheter and said sleeve in two positions or relative displacement of said catheter with respect to said sleeve, a hypodermic needle sealably fastened to the distal end of said catheter member inboard said diaphragm and proximate thereto, and actuating means sealed in iiuid communication with said catheter member, sealably and slidably engaging the inner proximal wall of said sleeve, said actuating means extending beyond the proximal end of said sleeve and displaceable a distance greater than the distance between the point of said needle and said diaphragm, said actuating means being adapted to receive a parenteral duid for delivery through said needle.

3. A catheter assembly comprising an elongated, bendable sleeve having an open proximal end and a sealed, pierceable distal end, a stiff, bendable, elongated catheter slidably mounted in said sleeve, a hypodermic needle sealingly secured to the distal end of said catheter and normally located inboard said piereeable end of said sleeve, a hollow locking member sealingly secured to the proximal end of said catheter and displaceable between a first position wherein the point of said needle is located inboard said pierceable end and a second position wherein the point of said needle extends beyond said pierceable end, means releasably interlocking said locking means and said sleeve in each of said first and second positions, and means secured to the proximal end of said locking member and in fluid communication therewith permitting resealable entry of a hypodermic needle therethrough.

4. A catheter assembly comprising: an elongated, bendable, resilient sleeve having an enlarged proximal end portion and an integral pierceable diaphragm sealing the distal end thereof, an elongated, stiff, bendable catheter slidably mounted in said sleeve, a hypodermic needle sealingly secured to the distal end of said catheter and normally located inboard and proximate said diaphragm, a rigid hollow adapter member sealingly secured to the proximal end of said catheter, a resilient male locking member formed internally at the proximal end of said sleeve, a rst pair of raised, spaced shoulders at the distal end of said adapter member adapted to sealingly grasp said male locking member therebetween, a resealable cap sealingly secured to the proximal end of said adapter member, a second pair of raised, spaced shoulders formed on said adapter member intermediate said first pair of spaced shoulders and said reseal cap and adapted to sealingly grasp said male locking member therebetween, said adapter member being displaceable between a rst position wherein said male locking member is sealingly grasped between said rst pair of shoulders and a second position wherein said male locking member is sealingly grasped between said second pair of shoulders, and a removable hood sealingly overlying said resealable cap.

S. A catheter assembly comprising: an elongated, bendable, resilient sleeve having an enlarged proximal end portion, an integral pierceable diaphragm sealingly closing the distal end of said sleeve, an elongated, stiif, bendable catheter slidably mounted in said sleeve, a hypodermic needle sealingly secured to the distal end of said catheter and having a piercing point normally located immediately adjacent and inboard said diaphragm, a rigid hollow lock member sealingly secured to the proximal end of said catheter, an inwardly extending male locking rib integrally formed at the proximal end of said sleeve, a pair of raised, spaced circular shoulders formed at the distal end of said lock member and adapted to sealingly grasp said locking rib therebetween, a resealable cap sealingly secured to the proximal end of said lock member, a locking groove peripherally formed on said lock member intermediate said cap and said pair of shoulders dened by a distal shoulder and a proximal stop ring and adapted to sealingly grasp said locking rib therebetween, said locking member being displaceable from a first position, wherein said locking rib is sealingly grasped between said pair of shoulders to a second position wherein said locking rib is sealingly grasped in said locking groove, the diameter of said stop ring being approximately the same as the outer diameter of the proximal end of said sleeve, and a removable hood sealingly overlying said resealable cap.

References Cited UNITED STATES PATENTS 2,531,667 ll/l950 Brent 12S-214.4 2,700,385 1/1955 Ortiz 128-215 2,740,404 4/1956 Kohl 12S-215 2,847,995 8/1958 Adams 12S-214 3,233,610 2/1966 Wade 12S-350 DALTON L. TRULUCK, Primary Examiner.

RCHARD A. GAUDET, Examiner. 

